Mycoses are infections caused by fungi, which comprise different groups of microorganisms—among which are dermatophytes—yeasts, molds etc., which can infect the skin (dermatophytoses), the hair (tinea), the nails (onychomycosis) and the genital areas (e.g. infections caused by Candida albicans).
Dermatophytes are fungi that need keratin to develop and that cause the formation of distinctive rosette-like maculae on the skin. Some dermatophytes can infect the scalp (tinea captis), the face (tinea faciei), the hands (tinea manuum), the torso (tinea corporis), the nails (tinea unguium) and the feet (tinea pedis or athlete's foot).
The yeasts (e.g. Candida albicans) are instead located in the warm and humid areas (oral cavity, armpits, interdigital spaces, genitalia). In particular, Candida Albicans can cause diseases at the corners of the mouth, the lips (cheilitis), the oral cavity (thrush), male and female genitalia and the nails.
The diagnosis of the mycoses avails itself of investigations by microscopy and/or culturings on biological material collected from the affected areas to detect the type of fungus responsible for the infection and select the most adequate antifungal therapy to treat such fungus.
Sometimes, the diagnosis process is not easy, also because the infections may be due to a plurality of fungi that can have different characteristics of sensitivity/resistance with respect to a given antifungal agent.
Consequently, topical treatment therapies performed with the conventional antifungal agents (e.g. econazole, fluconazole, ketoconazole, griseofulvin, amorolfine) can occasionally be not completely effective.
It is therefore desirable to have at disposal a therapeutic agent for the topical treatment of mycosis that presents a broad spectrum of action and that can be used with the highest safety.
In this regard, the antifungal effect of the Melaleuca Alternifolia (tea tree) extract is known since a long time and has been described for example by Nenoff P. et al. in Skin Pharmacol. 1996; 9(6):388-94.
The use of a liquid composition comprising the essential oils of tea tree (Melaleuca Alternifolia), lavender and eucalyptus for the treatment of onychomycosis is known from U.S. Pat. No. 6,413,555 too.
Moreover, the use of the oregano essential oil for the treatment of onychomycosis is known from WO 9637210.
KR 100285781 describes a composition with antifungal and antimicrobial activity containing oregano oil and another essential oil, which can be, among the others, tea tree oil.
A method for the treatment of a tissue affected by an infection caused by bacterial, fungal or viral pathogenic organisms, comprising the topical application of a composition comprising tea tree oil, an immunostimulant, typically coenzyme Q, and an antioxidant, typically vitamin E is known from the application US 2004/151710. In the description of this application it is stated that the antimicrobial action is due to the tea tree oil, while the coenzyme Q reinforces the immune response of the infected tissue and the antioxidant scavenges the free radicals in the infected tissue, thus contributing to the inhibition of the damage caused by the free radicals.
The antifungal activity of the lime essential oil towards several strains of fungi is reported in the article of Tagoe D. et al. “A Comparison of The Antimicrobial (Antifungal) Properties Of Garlic, Ginger And Lime On Aspergillus Flavus, Aspergillus Niger And Cladosporium Herbarum Using Organic And Water Base Extraction Methods”, The Internet Journal of Tropical Medicine, Vol. 7, No. 1.
WO 2015/144583 discloses a formulation for personal hygiene in the form of a O/W emulsion with a pH from 5.5 to 6.5, free of surfactants, comprising an emulsifier consisting of a fatty alcohol from 14 to 22 carbon atoms or of Glyceryl Stearate or a mixture thereof, Coco Caprylate and/or Coco Caprylate/Caprate, vitamin E or an ester thereof, and Melaleuca alternifolia oil.
WO 2016/051403 discloses an insect-repellant, fungicidal, bactericidal composite material for preservation of crops, the material including a non-woven fabric and a microencapsulated essential oil embedded in the non-woven fabric, wherein the microencapsulated essential oil can be selected among a huge number of essential oils, including lime, tea tree and oregano oils. The examples provided in the description envisage (example 1) the use of a fungicide (nefocide)+tea tree oil (or oregano oil)+rosemary oil or (example 2) the use of oregano oil (or tea tree oil)+rosemary oil. Effectiveness has been proven only for tea tree oil (example 8), mustard oil (example 8b) and oregano oil (example 8C).
US 2009/186096 discloses a method for the preparation of microencapsulated essential oils. Oregano and tea tree oils are mentioned among a high number of essential oils that can be used, together with possible additives, including i.a. vitamin E, for oral or topical application with a repelling action against insects and a bactericidal action. Lime oil is only mentioned among the essential oils that can be incapsulated as insect repellants or insecticides. This document is focused on the treatment of bovine mastitis, caused by bacterial infections.
Finally, U.S. Pat. No. 6,680,074 discloses a composition including propolis, oregano oil and at least one essential oil, for topical application and useful for treating microbial infections, including viral and mycotic infections. The above-mentioned essential oil can be i.a. Melaleuca alternifolia oil.